MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROBNP II; NATRIURETIC PEPTIDE TEST

Catalog Number	09315268160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys probnp ii on a cobas e411 rack analyzer.The sample initially resulted in a probnp value of 71.6 pg/ml.A doctor questioned the result because it did not match the patient's history.The sample was repeated, resulting in a probnp value of 4898 pg/ml.The repeat value was deemed correct and matched the patient's history.
Additional Manufacturer Narrative
No calibration influence was observed.Controls were within range before and after the event.A general reagent or analyzer issue was not present.Isolated non-reproducible results do not represent a general malfunction of the assay.A review of alarm trace data did not show any relevant alarms.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PROBNP II
• Common Device Name: NATRIURETIC PEPTIDE TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22636442
• Report Number: 1823260-2025-02315
• Device Sequence Number: 8155567
• Product Code: NBC
• UDI-Device Identifier: 07613336191569
• UDI-Public: 07613336191569
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K210546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09315268160
• Device Lot Number: 841698
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male